Dazed and confused [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-06-09 16:57  – Posting: # 21520
Views: 256

Hi Libaiyi,

» I had PK data from US. And now this drug needs to be put into other regions such as Asia. So we setup a new study, it is a single arm trial. How can I compare the PK data from the new trial to historical US PK data?

Never came across such a design.
Most agencies require a local reference product. Then you end up with a new comparative study. The US study is not relevant.
In the rare case where an agency accepts a foreign reference product (in your case the RLD), you could submit the US study.

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Helmut Schütz

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